Ignite Creation Date:
2024-05-06 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03662256
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2018-09-05
Brief Title:
Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine
Sponsor:
Norton Sound Health Corporation
Organization:
Norton Sound Health Corporation
Study Overview
Official Title:
Addressing Early Childhood Hearing Loss in Rural Alaska A Community Randomized Trial
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The population in rural Alaska which is predominately Alaska Native experiences a disproportionately high burden of hearing loss compared to the general US population The impact of untreated hearing loss in early childhood is tremendous and has grave implications for school achievement Preschool children with hearing loss experience speech and language delays and are less likely to be ready for kindergarten than their normal-hearing peers Early identification and treatment can reverse these ill effects Importantly the majority of hearing loss in this age group in rural Alaska is infection-mediated arising from acute and chronic otitis media that is treatable
In response preschool hearing screening is federally mandated at all Head Start centers across the country In accordance with this mandate hearing screening is already performed by the three organizations that offer early childhood education in the Norton Sound region Kawerak Inc RurAL CAP and Bering Strait School District
While the concept of screening in this age group is well established nationally what is less well understood is the optimal screening protocol for preschool children There is little evidence evaluating sensitivity and specificity of different screening protocols in this age group Further loss to follow up in the referral stage is a problem in preschool hearing screening just as it is in school hearing screening
Alaska has already developed innovative strategies to address hearing loss A network of village health clinics staffed by community health aides provide local care and telemedicine has been adopted in over 250 village clinics statewide Despite being widely available telemedicine has not yet been used to speed up the referral process for preventive services such as hearing screening
Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to evaluate hearing screening and referral processes in early childhood education in the Norton Sound region of northwest Alaska Preschool children will receive screening from the preschool and a new mHealth screening protocol These will be compared against a benchmark audiometric assessment to determine sensitivity and specificity Communities will then be randomized to continue the current primary care referral process or to adopt telemedicine referral The primary outcome will be time to ICD-10 earhearing diagnosis Secondary outcomes will include sensitivity and specificity of screening protocols and prevalence of hearing loss The goal of this study is to evaluate the optimal screening and referral strategy for preschool children in rural Alaska
In response preschool hearing screening is federally mandated at all Head Start centers across the country In accordance with this mandate hearing screening is already performed by the three organizations that offer early childhood education in the Norton Sound region Kawerak Inc RurAL CAP and Bering Strait School District
While the concept of screening in this age group is well established nationally what is less well understood is the optimal screening protocol for preschool children There is little evidence evaluating sensitivity and specificity of different screening protocols in this age group Further loss to follow up in the referral stage is a problem in preschool hearing screening just as it is in school hearing screening
Alaska has already developed innovative strategies to address hearing loss A network of village health clinics staffed by community health aides provide local care and telemedicine has been adopted in over 250 village clinics statewide Despite being widely available telemedicine has not yet been used to speed up the referral process for preventive services such as hearing screening
Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to evaluate hearing screening and referral processes in early childhood education in the Norton Sound region of northwest Alaska Preschool children will receive screening from the preschool and a new mHealth screening protocol These will be compared against a benchmark audiometric assessment to determine sensitivity and specificity Communities will then be randomized to continue the current primary care referral process or to adopt telemedicine referral The primary outcome will be time to ICD-10 earhearing diagnosis Secondary outcomes will include sensitivity and specificity of screening protocols and prevalence of hearing loss The goal of this study is to evaluate the optimal screening and referral strategy for preschool children in rural Alaska
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None